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FDA 510(k)

FPR THEOPHYLLINE KIT

K-Number: K894529 · 1989-09-15

ApplicantColony Laboratories, Inc.
Decision Date1989-09-15
Product CodeLGS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

FPR THEOPHYLLINE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Colony Laboratories, Inc.. It received FDA 510(k) clearance on 1989-09-15 under 510(k) number K894529. The device is classified under product code LGS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FPR THEOPHYLLINE KIT?

FPR THEOPHYLLINE KIT is a medical device that received FDA 510(k) clearance on 1989-09-15. The listed applicant is Colony Laboratories, Inc.. The 510(k) number is K894529.

When did FPR THEOPHYLLINE KIT receive FDA 510(k) clearance?

FPR THEOPHYLLINE KIT received FDA 510(k) clearance on 1989-09-15, under 510(k) number K894529.

Who is the listed applicant for FPR THEOPHYLLINE KIT?

The FDA 510(k) record lists Colony Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FPR THEOPHYLLINE KIT?

The FDA product code for FPR THEOPHYLLINE KIT is LGS.

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Other records listing Colony Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K894524FPR GENTAMICIN CALIBRATOR KITK894517FPR AMIKACIN KITK894523FPR GENTAMICIN KITK894518FPR AMIKACIN CALIBRATOR KITK894527FPR PHENYTOIN KITK894521FPR DIGOXIN KIT

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Related Devices (Code: LGS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K070810ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)Biokit, S.A.K955567INNOFLUOR THEOPHYLLINE ASSAY SYSTEMOxis Intl., Inc.K953016AXSYM THEOPHYLLINE IIAbbott LaboratoriesK951169CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAYCiba Corning Diagnostics Corp.K942991QMS THEOPHYLLINE CSSeradyn, Inc.K932127TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL IIAbbott Laboratories

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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